BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 2052272 · Received April 12, 2011

    Report

    Report Number
    2210968-2011-00415
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ETHICON, INC. - JUAREZ
    Product Code
    MNB
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 04/12/2011. (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENDOMETRIAL THERMAL ABLATION PROCEDURE ON (B)(6) 2011. DURING THE PROCEDURE, THERE WAS A SLIGHT SPIKE IN CATHETER PRESSURE IN THE WARM UP PHASE TO JUST OVER 205 WHICH STIMULATED A GENERATOR WARNING BUT THE SURGEON QUICKLY RELEASED THE PRESSURE AND COMPLETED THE PROCEDURE. FOUR DAYS AFTER THE PROCEDURE, THE PHYSICIAN CONFIRMED A THREE CENTIMETER BURN ON THE POSTERIOR VAGINAL WALL. THE PATIENT COMPLAINED OF PAIN. THE PHYSICIAN PRESCRIBED FLAMAZINE FOR ONE WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE CATHETER,BALLOON,TRANSCERVICAL MNB ETHICON, INC. - JUAREZ NA CKMG05

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention